MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS O WOUND PROTECTOR-RETRACTOR; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8405
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided upon the completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: alexis retractor tore in use.Clear film detached from green ring.Removed from abdomen.Retained for inspection.Intervention: removed from abdomen.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the inner ring separating from the sheath.Based on the condition of the returned unit and the description of the event, it is likely that the sheath was not properly heat sealed to the ring during manufacturing, causing a weak or incomplete film-to-ring seal.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: unknown.Event description: alexis retractor tore in use.Clear film detached from green ring.Removed from abdomen.Retained for inspection.Intervention: removed from abdomen.Patient status: no patient injury indicated.

• Brand Name: ALEXIS O WOUND PROTECTOR-RETRACTOR
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 22986530
• Report Number: 2027111-2025-00743
• Device Sequence Number: 15767095
• Product Code: KGW
• UDI-Device Identifier: 00607915127190
• UDI-Public: (01)00607915127190
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C8405
• Device Catalogue Number: 101477684
• Device Lot Number: 1536359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown